Methods and devices for endosonography-guided fundoplexy

ABSTRACT

The present invention relates to a tissue securement system, device and method for endoscopy or endosonography-guided transluminal interventions whereby a ligation or anchor is placed and secured into soft tissue. An objective of this invention is to provide a method to reduce gastroesophageal reflux by endosonography-guided intervention. Specifically, endosonography is used to insert a ligation element through the esophageal wall, through the diaphragmatic crus and into the fundus of the stomach. This ligation element placed from the esophagus and around the Angle of His to create a barrier to gastroesophageal reflux.

CLAIM OF PRIORITY

This application claims priority under 35 U.S.C. §119(e) to U.S.Provisional Application No. 60/688,837, filed Jun. 9, 2005, the entirecontents of which are hereby expressly incorporated by reference.

BACKGROUND

1. Field of the Invention

The present invention relates to a tissue securement system, device andmethod for endoscopy or endosonography-guided transluminal interventionswhereby a ligation or anchor is placed and secured into soft tissue.

2. Background of the Invention

Gastroesophageal reflux disease (GERD) is a chronic condition caused bythe failure of the anti-reflux barrier located at the gastroesophagealjunction to keep the contents of the stomach from refluxing back intothe esophagus.

Surgical fundoplication is the gold standard for anatomic correction ofthe cardia in patients with GERD. However this procedure can have a highincidence of postoperative complications and extended recovery times.Therefore endoscopic methods for enhancing the lower esophagealsphincter have been developed as an alternative to surgery. Endoscopictreatments of GERD target the esophageal and gastric wall in the regionof the lower esophageal sphincter. Methods including suture plication,radiofrequency energy ablation, and implant insertion are employed toprevent reflux by mechanisms that include the creation of a mechanicalbarrier by narrowing the lumen, altering the esophago-gastric angle(angle of His or “flap valve”), and altering the lower esophagealsphincter to enhance its function or decrease transient lower esophagealsphincter relaxations. The endoscopic methods can be performed entirelythrough the endoscope placed transorally, avoiding any abdominalincisions.

Endoscopic treatment is often limited because the operator can onlyvisualize the mucosal lining of the gastrointestinal wall that islocated directly in front of the endoscope. Structures deep within thewall, and outside the wall, cannot be seen. The ability to visualizethese structures may influence the proper placement of a treatmentapparatus and may expand the therapeutic strategies. For exampleplacement of a suture or ligating element through the esophageal andfundal walls that also includes placement through the diaphragmaticcrura may be useful. The use of endoscopic ultrasonography may addressthis limitation. In this procedure a combination endoscope andultrasound instrument called an echoendoscope is utilized. From thedistal esophagus, pertinent structures visualized with the echoendoscopeinclude the lower esophageal sphincter (LES) within the wall, the cruraldiaphragm, and the fundus of the stomach. The diaphragmatic crura aretypically seen interposed between the distal esophageal wall and thefundus of the stomach. One aspect of this invention utilizes thevisualization capabilities of ultrasound endoscopy to permit a noveldevice and method for treating GERD.

BRIEF SUMMARY OF THE INVENTION

Accordingly, an objective of this invention is to provide a method toreduce gastroesophageal reflux by endosonography-guided intervention.Specifically, endosonography is used to insert a ligation elementthrough the esophageal wall, through the diaphragmatic crus and into thefundus of the stomach. This ligation element placed from the esophagusand around the angle of His may create a barrier to gastroesophagealreflux.

The present invention is directed to a device, system and method that,as embodied and broadly described herein, includes an implantableligation element for fastening layers of tissue together. The ligationelement has proximal and distal ends and is suitable for insertionthrough the esophageal wall, the crura and into the fundus of thestomach. The distal end of the ligation element can be brought from thefundus, around the gastro-esophageal flap valve and secured to theproximal end of the ligation element in the esophagus. This ligatingelement forms a loop that can be used to draw the tissues describedtogether.

In a further aspect of the invention, a system for fastening tissue isprovided. The system includes a tissue securement apparatus that can beinitially positioned in the esophagus using an echoendoscope. Thesecurement apparatus is comprised of a hollow needle with a detachableneedle tip. A connecting element is positioned inside the needle andattached to the needle tip. When an inner stylet is advanced, the needletip separates from the needle body and the needle tip with a portion ofthe connecting element moves apart from the needle body to reside in thefundus of the stomach.

In another aspect of the invention, the system for fastening tissue alsoincludes a ligating element that can be attached to the proximal end ofthe connecting element once the hollow needle is removed. The ligatingelement may utilize a dilating element positioned at its distal end thatis sized to dilate a tissue tunnel so that the ligating element may bedrawn more easily through the tissue structures.

In still another aspect of the invention, the system may also utilize anendoscopically guided grasper to grasp the distal end of a connectingelement and pull the ligating element across the esophageal wall andinto the stomach. The system may also utilize a securement element thatis configured to engage the proximal and distal ends of the ligatingelement together. This may prevent the ligating element loop fromloosening.

In yet another aspect, the present invention includes a method oftreating gastroesophageal reflux disease. In the method, a ligatingelement having a proximal end and a distal end is passed transorallythrough the esophagus to a position near the junction between theesophagus and the stomach. The distal end of the ligating element isplaced through the wall of the esophagus, through a portion of thediaphragmatic crura and into the gastric fundus using ultrasonicguidance. The distal end of the ligating element is grasped in thefundus, wrapped around the gastro-esophageal flap valve and secured tothe proximal end of the ligation element in the esophagus.

All of these embodiments are intended to be within the scope of thepresent invention herein disclosed. These and other embodiments of thepresent invention will become readily apparent to those skilled in theart from the following detailed description of he preferred embodimentshaving reference to the attached figures. The invention is not limitedto any particular preferred embodiment(s) disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross sectional view of the esophageal-gastro-intestinaltract.

FIG. 2 is a view of the esophagus and stomach showing an echoendoscopeplaced in the distal portion of the esophagus;

FIG. 3 is a section view of a needle having a detachable needle tip;

FIG. 4 is a view similar to FIG. 2 showing the needle tip detached fromthe needle body after placement through a tissue wall;

FIG. 5 is a view of a ligating element with an attached dilatingelement;

FIG. 6 a is a view of a ligating element including one embodiment of asecurement element;

FIG. 6 b is a view of a ligating element showing an alternativeembodiment of a securement element;

FIG. 7 is a view showing a lower esophageal wall with a delivery needleinserted into the fundus from the esophagus;

FIG. 8 is a view showing a gastroscope in the stomach with an extendedgrasper capturing the retrieval loop on the needle tip;

FIG. 9 is a view showing a gastroscope in the lower esophagus with theligating element forming a loop around the gastro-esophageal flap valveand the stomach drawn up to the lower esophageal wall;

DETAILED DESCRIPTION OF THE INVENTION

The system and method described herein may offer improvements over thetechniques currently utilized to perform endoscopic procedures. Thistissue securement system has several embodiments that are intended towork together to create a novel device and method for the treatment ofGERD. However these embodiments also function independently and some ofthe embodiments of this system may be removed and the system may stillachieve its desired function. Alternatively several of these embodimentsmay be useful as stand alone devices. The principle elements of thissystem are; an echoendoscope, a delivery needle, a stylet, a needle tip,a connecting element, a ligating element and securement elements.

FIG. 1 is a cross sectional view of the esophageal-gastro-intestinaltract shown from the esophagus 1 to the stomach 2. The fundus 3 formsthe superior portion of the stomach 2. The esophagus 1 enters thestomach 2 at a point below the fundus 3 forming the cardiac notch 4 andan acute angle with respect to the fundus 3 known as the Angle of His 5.The lower esophageal sphincter (LES) 6 is an important primary sphincterthat controls the movement of fluids and food into the stomach. Thegastro-esophageal flap valve 7 includes a moveable portion and a morestationary portion. The moveable portion is a moveable flap that isformed at the junction of the esophagus 1 and the stomach 2. This flapis approximately 4-5 cm long and is partially held against the opposingwall of the stomach 2 by the internal pressures of the stomach. Theesophageal tract is primarily controlled by the LES 6 and thegastro-esophageal flap valve 7. When either the LES 6 or thegastro-esophageal flap valve 7 does not close properly the conditionknown as Gastroesophageal Reflux Disease (GERD) can occur. It is theintent of this invention to provide a treatment method for GERD bysupporting the LES 6 and the gastro-esophageal flap valve 7.

A first component of the tissue securement system, the delivery needle10, is shown in FIGS. 2 and 3 and is designed to be inserted through theinstrumentation channel of an endoscope or preferably an echoendoscope12. The delivery needle 10 can be manually advanced and retracted. Theproximal end of the delivery needle may include a handle (not shown)which can be secured to the inlet port of the instrumentation channel bya luer lock mechanism. The delivery needle 10 can be housed in aprotective outer sheath 18 which serves to protect the instrumentationchannel of an endoscope or echoendoscope from damage from the sharpneedle tip and to provide support as the delivery needle 10 is advanced.The outer sheath 18 can be manually advanced to cover the length of thedelivery needle 10.

In one embodiment shown in FIG. 3, the delivery needle 10 consists of aneedle body 20 which is constructed from a hollow tube and utilizes ahollow stylet 22 located coaxially inside. The delivery needle 10 issized to fit through the working channel of an echoendoscope althoughthis system may function equally well with larger diametricrequirements. The size of the delivery needle 10 is preferably 18 to 26gauge. More preferably the size is 19 to 23 gauge. A needle tip 24 islocated near the distal end 26 of the needle body and is detachablycoupled to the needle body 20. The needle body 20 has an inner diameter30 that provides support to the needle tip 24 during insertion. Theneedle tip 24 has a mating retention boss 32 located on the proximal endof the needle tip that is formed so that the needle tip 24 fits snuglyinside the inner diameter 30 of the needle body 20. Although a peg andhole arrangement is depicted in the drawings, various other featuressuch as a tongue and groove, a bayonet and slot or other commonmechanical stabilizing features could easily function with the sameintended result; to hold and support the needle tip 24 in position atthe end portion of the needle body 20 until the delivery needle isdeployed as described later.

A connecting element 40 is connected to the needle tip 24 at point 41and the connecting element 40 extends through the hollow pusher stylet22 to the proximal end of the needle where it can be manipulated by theoperator outside the patient's body. Upon advancement of the deliveryneedle 10 into soft tissue, the operator places tension on theconnecting element 40 which firmly seats the needle tip 24 in the needlebody 20. This facilitates the introduction of the needle body 20 andneedle tip 24 through tissue and into a targeted delivery site. Once atthe delivery site, the tension can be released. The connecting element40 is preferably a suture, thread, plastic filament or wire. The pusherstylet 22 extends along the length of the needle body 20 to the proximalend of the needle tip located at the retention boss 32.

Once the delivery needle 10 is advanced to a point where the needle tip24 is at the delivery site, the stylet 22 can be used to deploy theneedle tip 24 and connecting element 40. As shown in FIG. 4, when thestylet 22 is advanced the needle tip 24 separates from the needle body20 and the needle tip 24 and the attached connecting element 40 aredelivered to the delivery site. The stylet 22 is next withdrawn into theneedle body 20 and the delivery needle 10 can be withdrawn into theprotective sheath 18 inside the working channel of an endoscope orechoendoscope. The echoendoscope along with the delivery needle 10 isthen withdrawn leaving behind the needle tip 24 with the connectingelement 40 extending out through the patient's mouth. The needle tip 24helps prevent inadvertently pulling out the connecting element 40 fromthe soft tissue as the echoendoscope 12 and the delivery needle 10 arewithdrawn. The connecting element 40 can be attached to the proximal endof the needle tip at 41 or can be connected to a center portion of thetip so that the tip swivels away from the connecting element 40 furtherpreventing inadvertent pullout of the connecting element 40.

The needle tip 24 may utilize a retrieval loop 44 attached near its apex46 as illustrated in FIGS. 3 and 4. The retrieval loop 44 is a smallpiece of string or wire that is collapsed along the side of the needletip 24 while the needle tip 24 is inside the protective sheath 18. Theretrieval loop 44 expands once the needle tip 24 and connecting element40 are deployed as shown in FIG. 4. The retrieval loop 44 may bepositioned inside a groove 50 that is formed or cut into the side wall52 of the needle tip 24. The retrieval loop 44 may be important to guidethe needle tip 24 into the working lumen of a gastroscope as the needletip 24 and connecting element 40 are retrieved as part of the method ofthis application.

The delivery needle 10 has several potential advantages over otherdelivery systems that deliver T-tags, plugs or anchors. First, theworking channel of a standard echoendoscope has a small diameter in therange of 2.8 mm. This small size limits the size of the needle and T-tagthat can be delivered through the working channel. A T-tag may bepreloaded inside the hollow core of a needle, but this requires that theT-tag be very small for the procedure. T-tags of this size are difficultto handle by the physician and may be less effective. An alternative toplacing the T-tag within a needle requires multiple instrument exchangeswhereby first a needle is delivered to the intended site, a guidewire isinserted through the needle lumen, the needle coaxially exchanged for asheath over the guidewire and the guidewire removed so that a T-tag canbe delivered with a pushing stylet. The delivery needle 10 described inthis application facilitates a simple delivery of a 19-23 gauge needletip that acts like a T-tag. This delivery needle can save the operatortime and permit delivery of an anchor with a single instrument.

The system so far described is designed to deliver a connecting element40 and needle tip 24 through soft tissue to an intended delivery site.More preferably this system is designed to deliver the connectingelement 40 and the needle tip 24 through the esophageal and stomach wallfor the treatment of GERD. In this position, the connecting element 40can be used to pull another component of the system, a ligating element60, through soft tissue.

The ligating element 60 as shown in FIG. 5 is a length of material thatis suitable for long term contact with patient tissue, and is used totie together layers of soft tissue. It may be a suture, a tie, a thread,a band, a web, a strap, a belt, an elongated piece of mesh, a wire, or aTeflon patch. It may be a single filament or may be folded or coiled upfor delivery as illustrated in side “A” of FIG. 5 and then be deployedin an unfolded or uncoiled configuration as illustrated in side “B” ofFIG. 5 once in position. It should have enough bulk to reduce thepotential for pulling out of soft tissue when force is applied to theligating element 60. The ligating element 60 has a proximal end 62 and adistal end 64. The distal end 64 of the ligating element 60 can beconnected to the proximal end of the connecting element 40 outside thepatient's body. The distal end 64 of the ligating element may have adilating element 66 that is intended to dilate and widen the initialchannel through tissue formed by the connecting element 40. The dilatingelement 66 is a tapered element or bougie that has a diameter similar tothe connecting element 40 at its distal end and a diameter similar tothe ligating element 60 at its proximal end. It is formed or attachedcoaxially to the ligating element 60. As the ligating element 60 isdrawn into tissue, the dilating element 66 expands the lumen so that theligating element 60, which may have a larger profile, can transverse thelumen without high forces or causing clinically unacceptable tissuetrauma.

The proximal end 62 and distal end 64 of the ligating element 60 mayhave securement elements 70 and 72 respectively as illustrated in FIGS.6 a and 6 b. The securement elements 70 and 72 are designed to connectboth ends of the ligation element 60 together so that the ligationelement 60 forms a loop. The securement elements 70 and 72 mayincorporate an additional feature which will permit one way slippage sothat the diameter of the loop formed can be reduced but not increased.However the ligating element 60 may function equally as well without anysecurement elements incorporated into the ligating element 60. Byexample a simple crimping ferrule or wire clip may be utilized withsimilar results. The securement elements 70 and 72 function similarly toa string loop secured with a slip knot that can be pulled at one end andthe loop diameter reduced. As shown in FIG. 6 a, the securement element70 is a suture loop 74 attached to the proximal end of the ligatingelement 60 formed using a slip knot. The loop 74 is large enough so thata gastroscope can be introduced through the loop. As the distal end 64of the ligating element is brought through the loop 74, the loop reducesand secures the ligating element 60 in position.

Another embodiment of the securement element 70, shown in FIG. 6 b, hasa pre formed loop 80 attached to the proximal end 62 of the ligatingelement 60. The loop 80 is large enough so that a gastroscope can beintroduced through the loop 80. The dilating element 66 located near thedistal end 64 of the ligating element 60 has a series of grooves 82 thatare formed or cut in the side of the tapered dilating element 66. As thedilating element 66 is brought through the loop 80, the series ofgrooves 82 contact the pre formed loop 80 and the loop 80 successivelymoves into the recesses of the grooves. This prevents the dilatingelement 66 from pulling out of the loop 80 but the ligating element 60can be successively tightened as the dilating element 66 is drawn intothe loop 80. Many other types of securement elements such as a rack andpinion, mechanical ratchet are possible and the examples illustratedhere are not meant to be limiting. In fact many other suture retentionapparatus are equally feasible as known to those in the art.

Methods of treating GERD are discussed with reference to FIGS. 1-8.Although the invention is described in connection with the structureshown in these figures, and in connection with treating GERD, it shouldbe understood that the system in its broadest sense is not so limited.

As shown in FIG. 7, an echoendoscope 12 is positioned through thepatient's esophagus 1 to a position near the lower esophageal sphincter(LES) 6. Although an endoscope 12 may be used an echoendoscope ispreferred so that structures and hollow spaces that are positionedbehind tissue walls can be visualized. When the echoendoscope 12 isproperly positioned, the working channel is directed toward the innerwall of the esophagus 100 and the delivery needle 10 is advanced. Thedelivery needle 10 pierces the esophageal wall 100 and is then directedthrough the diaphragmatic crura 106 under ultrasonic guidance andthrough the wall of the stomach 108 and into fundus 3. It is importantthat the delivery needle 10 transverse the diaphragmatic crura 106because is thought that this is a stable structure that will anchor thesystem as opposed to anchoring to soft tissue alone. Once the distal end26 of the delivery needle is positioned in the fundus 3, the stylet 22is advanced to separate the needle tip 24 from the needle body 20. Theneedle tip 24 with the attached connecting element 40 is deposited inthe fundus 3 and the delivery needle 24 is withdrawn. The echoendoscope12 can be withdrawn leaving behind the connecting element 40 extendingfrom the fundus 3 to the mouth of the patient.

The distal end 64 of the ligating element is attached to the proximalend of the connecting element 40 outside the patient's body. As shown inFIG. 8, a gastroscope 112 is then inserted into the patient's mouth downthe esophagus 1 and into the stomach and positioned so that the needletip 24 and the retrieval loop 44 can be visualized. A grasper 114 isextended from the working channel of the gastroscope 112 and it grabsthe retrieval loop 44 of the needle tip 24. The needle tip 24 andconnecting element 40 are pulled by the grasper 114 into the workinglumen of the gastroscope. The connecting element 40 in turn pulls theligating element 60 down the esophagus 1 through the esophageal wall 100and into the fundus 3. The ligating element 60 is drawn near the end ofthe gastroscope and the gastroscope is withdrawn from the stomach to aposition near the LES 6 as shown in FIG. 9. When the securement elements70 and 72 are brought into close proximity to each other, a loop 120consisting primarily of the ligating element is formed. This loop 120formed when the ligating element 60 transverses the esophageal wall 100,the diaphragmatic crura 106, and the fundus 3 of the stomach, around thegastro-esophageal flap valve 7 and back to the esophageal wall 100.

An important feature of the securement elements is that the securementformed between the two ends of the ligating element is slidable so thatthe diameter of the loop 120 can be reduced to cinch various anatomicalfeatures together. By cinching down the loop 120, the fundus 3 of thestomach 2 is drawn into close proximity with the esophageal wall 100.This causes the stomach 2 to be partially wrapped around the esophagusso that esophagus 1 and stomach 2 are positioned in a method similar toa Nissen fundoplication procedure. As the internal pressure of thestomach 2 increases during digestion, the stomach applies a compressiveforce to the esophagus 1 that tends to reduce the internal luminaldiameter of the esophagus. The compressive force reduces the likelihoodof the stomach contents being able to pass through the esophagus 1. Inother words the lower esophagus functions like a properly functioninglower esophageal sphincter.

This invention has been described and specific examples of the inventionhave been portrayed. The use of those specifics is not intended to limitthe invention in anyway. Additionally, to the extent that there arevariations of the invention, which are within the spirit of thedisclosure or equivalent to the inventions found in the claims, it is myintent that this patent will cover those variations as well.

What is claimed is:
 1. A method for treating gastroesophageal refluxdisease comprising: inserting a tissue securement apparatus through anesophageal wall, a diaphragmatic crura and a fundal wall of a stomach;advancing a connecting element into the stomach; joining the proximalend of the connecting element to a ligating element; pulling theconnecting element to position the ligating element across theesophageal wall, the diaphragmatic crura and the fundal wall of thestomach; and fastening the esophageal wall to the fundal wall with theligating element to capture the diaphragmatic crura between the walls.2. A method for connecting a first body cavity having an esophageal wallto a stomach having a fundal wall comprising: inserting a tissuesecurement apparatus containing a needle with proximal and distal endportions, through the esophageal and fundal walls, wherein the needlecomprises a hollow needle body, a detachable sharpened needle tip, astylet positioned coaxially inside the needle body, and a connectingelement coupled to the needle tip, wherein the tip directly penetratesthe walls and a diaphragmatic crura to position the needle tip in thestomach; removing the needle body while engaging the stylet against theneedle tip to disengage the needle tip from the needle body to leave theneedle tip and a portion of the connecting element remaining in thestomach; joining a proximal end of the connecting element to a ligatingelement, positioning a grasping forceps inside the stomach and graspingand pulling a distal end of the connecting element to position theligating element across the esophageal and fundal walls; and bringingthe ends of the ligating element together to form a loop that draws theesophageal and fundal walls together.
 3. The method of claim 2 furthercomprising delivering the tissue securement apparatus to the first wallusing an endoscope or echoendoscope.
 4. The method of claim 2 wherebythe formed loop traverses around the Angle of His.
 5. The advancing stepof claim 2 further comprising moving the stylet distally to detach theneedle tip from the needle body and position the needle tip with aportion of the connecting element in the stomach.
 6. The method of claim2 further comprising securing the ends of the ligating element with asecurement element.
 7. A method for repairing a gastroesophageal flapvalve comprising: positioning a tissue securement apparatus containing aneedle with proximal and distal end portions along the esophageal wallwherein the needle comprises a hollow body, a detachable sharpened tip,a stylet positioned coaxially inside the needle body and a connectingelement coupled to the needle tip, inserting the tissue securementapparatus through the esophageal wall, the diaphragmatic crura and afundal wall of the stomach, wherein the sharpened needle tip directlypenetrates the walls to position the needle tip in the stomach,advancing the sylet to push the sharpened needle tip from the needlebody so that the needle tip is left in the stomach, advancing theconnecting element into the stomach, withdrawing the needle body,joining a proximal end of said connecting element to a ligating element,positioning grasping forceps inside the stomach, grasping and pullingthe connecting element to position the ligating element across theesophageal wall, the diaphragmatic crura and a fundal wall of thestomach, and bringing the ends of the ligating element together to forma loop that encircles the gastro-esophageal flap valve and draws theesophageal and fundal walls together.
 8. The method of claim 7 furthercomprising positioning the apparatus with an echoendoscope and usingultrasonic guidance to locate the diaphragmatic crura.
 9. The advancingstep of claim 7 further comprising moving the stylet distally to detachthe needle tip from the needle body and position the needle tip with aportion of the connecting element in the stomach.
 10. The method ofclaim 7 further comprising securing the ends of the ligating elementwith a securement element.
 11. The method of claim 7 further comprising:bringing the ends of the ligating element together to form a loop thatencircles the Angle of His and draws the esophageal and fundal wallstogether.
 12. The ligating element of claim 7 further comprising aninitially folded or coiled configuration suitable for delivery and anunfolded or uncoiled configuration once deployed.
 13. The ligatingelement of claim 7 wherein the ligating element is a suture, tie,thread, band, cord, web, strap, belt, elongated piece of mesh, wire, ora biocompatible patch.